ALLY-3
is the first Phase 3 study of an all-oral, ribavirin-free
treatment regimen for genotype 3 HCV patients with a 12-week treatment
duration

Genotype 3 is the second most common genotype worldwide and has emerged as one of the most difficult to treat

Saturday, November 8, 2014 9:00 am EST--"Both treatment naïve and treatment experienced patients in the ALLY-3
study achieved high SVR rates. These results are encouraging
given that patients with genotype 3 have emerged as among the
hardest to treat"

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers
Squibb Company (NYSE:BMY) today announced late-breaking data from
the landmark ALLY Trial investigating a ribavirin-free 12-week regimen
of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3
hepatitis C (HCV) patients, a patient population that has emerged as one
of the most difficult to treat. The results of the study, which showed
sustained virologic response 12 weeks after treatment (SVR12) in 90% of
treatment-naïve and 86% of treatment-experienced patients, will be
presented at The Liver Meeting® 2014, the Annual Meeting of
The American Association for the Study of Liver Diseases (AASLD), in
Boston, MA, November 7 – 11.

“Both treatment naïve and treatment experienced patients in the ALLY-3
study achieved high SVR rates. These results are encouraging given that
patients with genotype 3 have emerged as among the hardest to treat,”
said David R. Nelson, M.D.,Professor of Medicine, Molecular
Genetics and Microbiology Director, UF Clinical and Translational
Science Institute, and Assistant Vice President of Research for the
University of Florida. “Genotype 3 is associated with a more rapid
progression of disease and remains a challenge to the efficacy of even
newer regimens. The ALLY-3 results demonstrate the possibility of
bringing a cure to genotype 3 patients in an all-oral, 12-week regimen.”

These results build upon the existing body of data on the daclatasvir
and sofosbuvir combination. Data from an open-label, randomized study
of daclatasvir with sofosbuvir in genotypes 1, 2, and 3 demonstrated
that the 24-week regimen of daclatasvir and sofosbuvir (± ribavirin)
achieved SVR12 in 89% of patients with genotype 3. The ALLY study
presented at The Liver Meeting investigates the regimen for 12 weeks,
halving the previous treatment duration. Other ongoing ALLY studies
examine diverse HCV populations across all genotypes: cirrhotic and
post-liver transplant patients, as well as treatment-naïve and
treatment-experienced patients who are co-infected with HIV.

“HCV is a complex disease, and the treatment community needs multiple
options to address the remaining unmet medical needs,” said Douglas
Manion, M.D., head of Specialty Development, Bristol-Myers Squibb.
“Daclatasvir has shown pan-genotypic activity in bench research, a
factor which is becoming increasingly important as we learn more about
the complexity of HCV. Further, daclatasvir’s potential to be combined
with many other agents, including sofosbuvir, is significant in
continuing to develop additional treatment options that may help
patients of all genotypes achieve cure.”

In the ALLY-3 study, the daclatasvir and sofosbuvir combination regimen
was well tolerated, with no deaths, treatment-related serious adverse
events, or discontinuations due to adverse events. The most frequent
side effects (≥5%) were headache (19.7%), fatigue (19.1%), nausea
(11.8%), diarrhea (8.6%), insomnia (5.9%), abdominal pain and arthralgia
(both 5.3%). Additionally, there were 17 (11.2%) treatment failures,
with 16 relapses post-treatment and 1 rebound at the end of treatment.
There were no viral breakthroughs in this ribavirin-free regimen.

The full abstract for the presentation is available at The Liver Meeting website.
About Bristol-Myers Squibb’s HCV Portfolio
Bristol-Myers Squibb’s research efforts are focused on advancing
late-stage compounds to deliver the most value to patients with
hepatitis C. At the core of our pipeline is daclatasvir, a potent
pan-genotypic NS5A complex inhibitor (in vitro), which continues
to be investigated in multiple treatment regimens and in people with
co-morbidities.

Daklinza (daclatasvir) was recently approved in the EU for use in
combination with other medicinal products across genotypes 1, 2, 3 and 4
for the treatment of chronic hepatitis C virus (HCV) infection in
adults. Daklinza is also approved in Japan in combination
with Sunvepra (asunaprevir), a NS3/4A protease inhibitor.
The Daklinza+Sunvepra Dual Regimen is Japan’s first
all-oral, interferon- and ribavirin-free treatment regimen for patients
with genotype 1 chronic HCV infection, including those with compensated
cirrhosis.

In 2013, Bristol-Myers Squibb’s investigational all-oral DCV-TRIO
regimen (daclatasvir/asunaprevir/beclabuvir) received Breakthrough
Therapy Designation in the U.S., which helped to expedite the start of
the ongoing Phase 3 UNITY program. Study populations include
non-cirrhotic naïve, cirrhotic naïve and previously treated patients. In
addition to UNITY 1 and 2, both the UNITY-3 study among Japanese
treatment-naïve and -experienced genotype 1 patients and UNITY-4, which
studies the DCV-TRIO regimen without ribavirin in cirrhotic and
non-cirrhotic patients in Korea, Russia and Taiwan, are currently
ongoing. The DCV-TRIO regimen is being studied as a
fixed-dose-combination treatment with twice daily dosing.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information, please
visit http://www.bms.com or
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